CLINICAL TRIALS PROFILE FOR HYLENEX RECOMBINANT

All Clinical Trials for Hylenex Recombinant

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00311519 ↗	A Phase IIIB Dose Comparison Study of Subcutaneous Hydration With and Without Human Recombinant Hyaluronidase (HYLENEX) in Volunteer Subjects	Completed	Halozyme Therapeutics	Phase 4	2005-11-01	The purpose of this research study to test the effectiveness of a study medication to increase how fast a solution called lactated Ringer's is absorbed when put under the skin subcutaneously. The medication to be studied is an enzyme called hyaluronidase, and is a human recombinant form of the enzyme. The drug company name for this medication is Hylenex. Hylenex was currently an investigational medication at the initiation of the study, but received FDA approval during the study. An investigational medication is a medication or formulation of a medication that is not approved by the United States Food and Drug Administration for use in this country but may be used in studies such as this one.
NCT00435604 ↗	A Study of the Subcutaneous Injection of a Viscous Antibody Solution With Recombinant Human Hyaluronidase	Completed	Halozyme Therapeutics	Phase 1	2007-02-01	This Phase I, randomized, double-blinded, within-subject controlled, two-way crossover study comparing the time to inject (flow rate), safety, and tolerability of a subcutaneously (SC) administered, viscous antibody solution of with and without human recombinant hyaluronidase (rHuPH20) in volunteer subjects. The study hypothesizes that the time required to complete a 20-mL SC injection of a viscous antibody with rHuPH20 will be comparable or shorter than the time required for the injection without rHuPH20.
NCT00477152 ↗	Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase for Infants and Children	Completed	Halozyme Therapeutics	Phase 4	2007-08-01	The aim of the study is to evaluate the safety, effectiveness and ease of use of subcutaneous (SC) rehydration using HYLENEX-augmented SC infusion of fluids and electrolytes for the rehydration of pediatric patients with mild to moderate dehydration.
NCT00477152 ↗	Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase for Infants and Children	Completed	PPD	Phase 4	2007-08-01	The aim of the study is to evaluate the safety, effectiveness and ease of use of subcutaneous (SC) rehydration using HYLENEX-augmented SC infusion of fluids and electrolytes for the rehydration of pediatric patients with mild to moderate dehydration.
NCT00477152 ↗	Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase for Infants and Children	Completed	Baxter Healthcare Corporation	Phase 4	2007-08-01	The aim of the study is to evaluate the safety, effectiveness and ease of use of subcutaneous (SC) rehydration using HYLENEX-augmented SC infusion of fluids and electrolytes for the rehydration of pediatric patients with mild to moderate dehydration.
NCT00493220 ↗	Pharmacokinetic and Safety Study of HYLENEX Recombinant-Augmented Subcutaneous Ceftriaxone Administration	Completed	Halozyme Therapeutics	Phase 1	2007-06-01	The objectives of this study are: - to establish the safety of subcutaneous administration of ceftriaxone at different concentrations, with and without HYLENEX recombinant, and to determine the maximum tolerated concentration; - and to establish the pharmacokinetic comparability of subcutaneous administration of ceftriaxone with HYLENEX recombinant to subcutaneous administration without HYLENEX recombinant and to IV administration.
NCT00493220 ↗	Pharmacokinetic and Safety Study of HYLENEX Recombinant-Augmented Subcutaneous Ceftriaxone Administration	Completed	Baxter Healthcare Corporation	Phase 1	2007-06-01	The objectives of this study are: - to establish the safety of subcutaneous administration of ceftriaxone at different concentrations, with and without HYLENEX recombinant, and to determine the maximum tolerated concentration; - and to establish the pharmacokinetic comparability of subcutaneous administration of ceftriaxone with HYLENEX recombinant to subcutaneous administration without HYLENEX recombinant and to IV administration.

Clinical Trial Conditions for Hylenex Recombinant

Condition Name

Condition Name for Hylenex Recombinant
Intervention	Trials
Dehydration	8
Healthy	6
Type 1 Diabetes Mellitus	6
Diabetes Mellitus	2

Condition MeSH

Condition MeSH for Hylenex Recombinant
Intervention	Trials
Diabetes Mellitus	12
Diabetes Mellitus, Type 1	8
Dehydration	8
Diabetes Mellitus, Type 2	2

Clinical Trial Locations for Hylenex Recombinant

Trials by Country

Trials by Country for Hylenex Recombinant
Location	Trials
United States	93
Kenya	1
China	1

Trials by US State

Trials by US State for Hylenex Recombinant
Location	Trials
California	14
Texas	7
Michigan	6
Florida	6
Montana	4

Clinical Trial Progress for Hylenex Recombinant

Clinical Trial Phase

Clinical Trial Phase for Hylenex Recombinant
Clinical Trial Phase	Trials
Phase 4	11
Phase 3	1
Phase 2	8

Clinical Trial Status

Clinical Trial Status for Hylenex Recombinant
Clinical Trial Phase	Trials
Completed	29
Terminated	1
Withdrawn	1

Clinical Trial Sponsors for Hylenex Recombinant

Sponsor Name

Sponsor Name for Hylenex Recombinant
Sponsor	Trials
Halozyme Therapeutics	23
Baxter Healthcare Corporation	10
Massachusetts General Hospital	2

Sponsor Type

Sponsor Type for Hylenex Recombinant
Sponsor	Trials
Industry	37
Other	14
NIH	1

Hylenex Recombinant: Clinical Trials, Market Analysis, and Projections

Introduction to Hylenex Recombinant

Hylenex recombinant (hyaluronidase human injection) is an endoglycosidase that serves as an adjuvant to enhance the dispersion and absorption of other injected or subcutaneously infused drugs. It is the only FDA-approved recombinant human hyaluronidase, making it a significant player in the medical field[2].

Clinical Trials Update

CONSISTENT 1 Trial

One of the notable clinical trials involving Hylenex recombinant is the CONSISTENT 1 trial. This trial evaluates the safety and efficacy of Hylenex recombinant and a new formulation of Hylenex in patients with type 1 diabetes receiving continuous subcutaneous insulin infusion (CSII). The trial demonstrated that the primary endpoint of non-inferiority of A1C levels at six months was met. Additionally, the trial showed a reduction in hypoglycemic events, with a 12% reduction in overall hypoglycemic events and a 61% reduction in severe hypoglycemic events requiring third-party assistance[1].

Key Findings

• Hypoglycemia Reduction: The trial highlighted a significant reduction in hypoglycemic events, which is a critical unmet medical need in the treatment of type 1 diabetes.
• Safety Profile: Adverse events were similar across the treatment and control groups, with mild infusion site discomfort being the most common treatment-related adverse event.
• Efficacy: The data from the CONSISTENT 1 trial will be used to seek an update to the Hylenex label with the FDA to include key efficacy and safety data[1].

CheckMate -67T Trial

Another significant trial involving Hylenex recombinant is the CheckMate -67T trial conducted by Bristol Myers Squibb. This Phase 3 trial evaluated the subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20) compared to intravenous Opdivo in patients with advanced or metastatic clear cell renal cell carcinoma. The trial demonstrated noninferior pharmacokinetics, efficacy, and safety of the subcutaneous formulation compared to the intravenous formulation[4].

Market Analysis

Global Hyaluronidase Market

The global hyaluronidase market, which includes Hylenex recombinant, was estimated at USD 909.5 million in 2022 and is anticipated to grow at a CAGR of 8.4% from 2023 to 2030. The market is driven by various applications, with the dermatology segment holding the largest revenue share of approximately 44.6% in 2022[5].

Segment Analysis

• Dermatology: This segment dominates the market due to the increasing use of hyaluronidase in dermatological treatments.
• Chemotherapy: The chemotherapy segment is expected to register the fastest CAGR of 10.5% over the forecast period, driven by its utility in resolving extravasation and enhancing tumor response to chemotherapeutic drugs[5].

Type Analysis

• Animal-Derived vs. Recombinant: While animal-derived hyaluronidase held the largest revenue share of 67.0% in 2022, the recombinant human hyaluronidase segment is anticipated to register the fastest CAGR of 9.4% due to its high efficacy, consistency, and purity[5].

Regional Analysis

• North America: This region dominated the market in 2022 with the largest revenue share of 38.0%, driven by the presence of major players and high adoption of advanced treatment options.
• Asia Pacific: This region is expected to grow at the fastest CAGR of 9.3% during the forecast period, driven by medical tourism and the advent of technology in countries like South Korea[5].

Market Projections

Growth Drivers

• Increasing Demand for Advanced Treatments: The growing demand for innovative healthcare solutions, particularly in dermatology and chemotherapy, is driving the market growth.
• Clinical Trials and Approvals: Successful clinical trials, such as the CONSISTENT 1 and CheckMate -67T trials, are expected to expand the indications and usage of Hylenex recombinant, contributing to market growth[1][4].

Market Size

The global hyaluronidase market is projected to reach USD 1.43 billion by 2030, growing at a CAGR of 8.4% from 2023 to 2030. This growth is supported by the increasing adoption of recombinant human hyaluronidase and the expansion of its applications in various medical fields[5].

Key Takeaways

• Clinical Efficacy: Hylenex recombinant has demonstrated significant clinical efficacy in reducing hypoglycemic events in type 1 diabetes patients and in enhancing the pharmacokinetics of subcutaneous formulations of drugs like Opdivo.
• Market Growth: The global hyaluronidase market is poised for substantial growth, driven by increasing demand in dermatology and chemotherapy, and the preference for recombinant human hyaluronidase.
• Regional Expansion: North America and Asia Pacific are key regions driving the market growth, with Asia Pacific expected to show the fastest growth rate.

FAQs

What is Hylenex recombinant used for?

Hylenex recombinant is used as an adjuvant to increase the dispersion and absorption of other injected or subcutaneously infused drugs. It is also used to facilitate subcutaneous fluid administration and in subcutaneous urography[2].

What were the key findings of the CONSISTENT 1 trial?

The CONSISTENT 1 trial showed that Hylenex recombinant met the primary endpoint of non-inferiority of A1C levels at six months and reduced hypoglycemic events in patients with type 1 diabetes receiving CSII[1].

How does the subcutaneous formulation of Opdivo with Hylenex recombinant compare to the intravenous formulation?

The subcutaneous formulation of Opdivo co-formulated with Hylenex recombinant demonstrated noninferior pharmacokinetics, efficacy, and safety compared to the intravenous formulation in the CheckMate -67T trial[4].

What is the projected growth rate of the global hyaluronidase market?

The global hyaluronidase market is anticipated to grow at a CAGR of 8.4% from 2023 to 2030[5].

Which segment is expected to grow the fastest in the hyaluronidase market?

The chemotherapy segment is expected to register the fastest CAGR of 10.5% over the forecast period, driven by its utility in resolving extravasation and enhancing tumor response to chemotherapeutic drugs[5].

Sources

1. Halozyme Announces that Consistent 1 Trial Of Hylenex Recombinant Met Primary Endpoint - PR Newswire
2. Hylenex: Home - Hylenex.com
3. U.S. Clinical Trials Market Size Industry Analysis Report, 2033 - Biospace
4. CheckMate -67T Trial - Bristol Myers Squibb
5. Hyaluronidase Market Size & Share Analysis Report, 2030 - Grand View Research

Last updated: 2024-12-31